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Bariatric Surgery (Gastroplasty): Clinical Library
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ADULT CARE: DIGESTIVE SYSTEM > CLINICAL GUIDELINES
KAISER PERMANENTE OHIO
BARIATRIC SURGERY (GASTROPLASTY)
Methodology: Expert Opinion
Champion: Surgery
Key Stakeholders: Surgery, IM Depts.
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Issue Date: 12-05
Review Date: 4-10, 4-12, 1-13
Next Update: 1-14
RELEVANCE:
The CPG for Bariatric Surgery has been developed by a multidisciplinary team, who has both experience with, and an interest in the
treatment of the morbidly obese patient. Recently there has been an explosion of information regarding the high incidence and near
epidemic proportions of Morbid Obesity and associated comorbidities and their relationship to morbidity, mortality and health care
spending. Evidence supports Roux en Y gastric bypass (RYGB) and laparoscopic Roux en Y Gastric Bypass (LRYGB) procedures as
permanent measures that may be appropriate for a select subset of the obese population. These procedures have a long record of
outcomes including weight loss, resolution of comorbidities and short and long term complications. Recent evidence support
laparoscopic adjustable gastric banding (LAGB) and laparoscopic sleeve gastrectomy (LSG) as alternative procedures. The evidence
is not as long term. The weight loss and resolution of comorbidities occur more slowly and to a lesser degree than either RYGB or
LRYGB with LAGB although literature reported morbidity and mortality are lower, however. LSG has weight loss and comorbidity
resolution similar to LRYGB, and superior to LAGB. The complication rates of LSG are similar to LAGB and higher than LAGB. The
LAGB requires more frequent follow–up for potential adjustments, and is reversible. Studies have shown survival advantage for
patients who undergo bariatric surgery and that the overall complication rates of bariatric surgeries performed at centers of
excellence are similar to those seen in less complicated abdominal surgeries. By standardizing the teaching, screening and selection
process we expect to decrease patient and provider confusion and maximize compliance with life changes required for post–op
success. We expect decreased costs to the system as a whole initially, by internalizing the procedure as well as specialty consults.
Long term we would expect to decrease morbidity by improving comorbid conditions such as hypertension, diabetes, hyperlipidemia
and sleep apnea with a corresponding decrease in the number of pharmaceutical and durable medical equipment needed. We also
expect increase in patient's quality and duration of life as a result of improvement in comorbid conditions associated with obesity.
ENTRY CRITERIA:
A. Weight Loss Attempts:
Previous failed attempts at weight loss will need to be documented. Patients are expected to lose up to 5% of their body weight from
the time that they enroll in the program until surgery is performed. Exceptions may be made on an individual case by case basis.
B. BMI Criteria:
Patients with a BMI at time of entry into the program of at least 40 require no comorbidities. Patients with a BMI under 35 are
excluded. Patients with a BMI at time of entry into the program of greater than 35 but less than 40 must have at least one of the
comorbidities listed below.
C. Approved Comorbidities:
Diabetes
Hypertension
Hyperlipidemia
Obstructive Sleep Apnea with use of a CPAP mask for at least 2 months before surgery
D. Age:
Patients must be at least 18 years of age.
EXCLUSION CRITERIA:
A. Psychiatric Disorders
Patients with major psychiatric disorders that limit their ability to achieve the life style changes necessary for success are excluded.
B. Other (contraindications)
Patients who are pregnant or desire pregnancy within two years of starting the program are excluded. Patients with a projected life
expectancy from conditions not expected to be improved by the surgery (i.e. malignancy) of less than 3 years are excluded.
Documentation must be provided by the provider caring for this condition in this patient. Cigarette smoking must be stopped for at
least 3 months prior to surgery. Exogenous estrogen must be stopped for at least 3 months prior to surgery. Tight glycemic control
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Bariatric Surgery (Gastroplasty): Clinical Library
with an HgA1c less than 7.5 is desired. Other conditions that present prohibitive risks for surgery shall be evaluated on an individual
basis.
C. BMI Upper Limits of Eligibility
All patients are evaluated individually based upon comorbidities and risks. Patients weighing more than the safe weight limits of the
hospital beds and imaging systems (currently 450 lbs) will be considered for referral to a tertiary care center on an individual basis.
D. Physical Activity
Patients with poor potential for physical rehabilitation are excluded. An example would be a patient with end stage pulmonary
hypertension with cardiomyopathy.
E. History of Bariatric Surgery
Failed weight loss or weight regain are not indications for secondary (revisional) Bariatric Surgery. There is insufficient evidence to
show that additional surgery in these cases is of benefit. These patients are best managed by Behavioral Health and Nutritional
Services. A small subset of patients will have surgical complications (staple line disruptions with fistula formation, band slippage,
etc.) that warrant surgical intervention. All patients considering secondary Bariatric Surgical procedures will be evaluated to
determine the presence of any surgical complications.
PRE–APPROVAL ASSESSMENT AND MANAGEMENT PROGRAMS
A. Multidisciplinary Team
A multidisciplinary team consisting of, but not limited to, the RN Case Manager, Bariatric Surgeons, representatives from Nutrition
Services, Behavioral Health, Internal Medicine, and Wound Care shall meet at least once each month. Their function is to review
patients prior to surgical consultation, and share concerns that each discipline may have concerning the patient. In addition, issues
concerning post–operative patients may also be discussed as needed. They will also review issues concerning the Bariatric Surgery
program as they arise, and share educational information concerning Bariatric Surgery and Obesity related issues.
B. Orientation
When a patient is referred to the program, they will receive an orientation concerning the structure of the program by the RN Case
Manager. All patients have the option of attending preoperative orientation programs sponsored at Parma Community General
Hospital. At the discretion of the RN Case Manager, individual cases will be presented to the Bariatric Surgeon prior to entry into the
program in order to insure that they are suitable candidates.
C. Nutrition Assessment
All patients must be involved with the nutrition program for at least 6 visits over at least a 6 month period of time to include
assessment of nutritional status, nutritional knowledge, eating patterns and readiness to make behavioral change. They must
demonstrate understanding of the dietary changes required for weight loss after surgery.
D. Medical Evaluation
All patients shall have a history and physical performed by their primary care physician with special attention paid to screening for
comorbidities and making appropriate specialty referrals. A baseline set of blood work will also be ordered, including CBC, CMP, lipid
panel, TSH, and PTH. HgA1c and EKG will be ordered when indicated. Referral into the Bariatric program must be made by the
primary care physician.
E. Mental Health Intake Appointment
An Intake assessment is scheduled in BHS after at least 2 visits with the dietitian are completed, unless referred sooner by the
bariatric surgery team.
F. Mental Health Intake Assessment
At least 1–2 BHS visits for completion of the assessment which includes:
a. Completing the requirements of a routine Intake assessment with a particular focus on issues related to food and weight
management to identify:
any major psychiatric disorders that would render surgery contraindicated (i.e. anorexia, bulimia, psychosis, substance
abuse, borderline personality disorder),
disorders that require further psychiatric intervention (i.e. major depression, panic disorder), or
Issues that potentially could interfere with a successful surgical outcome (i.e. emotional eating/primarily using food to
cope).
b. Assessment of the following areas to determine realistic expectations of the surgery and motivation/readiness for behavioral
change:
weight loss history and outcomes,
impact of obesity on lifestyle and relationships,
level of knowledge about the surgery,
reasons for seeking the surgery and expected outcomes including potential barriers to success,
The role of food in their life and their planned substitute post operatively.
c. Identifying evidence of an ability to comply and commit to post operative diet and lifestyle changes i.e.,) history of follow
through and compliance in other life areas such as dietitian visits, diabetes/HTN regime, medical visits etc.
d. An evaluation of the social system to identify the availability of resources to support the patient before and immediately after
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Bariatric Surgery (Gastroplasty): Clinical Library
surgery, and over the post operative course.
e. Communication and collaboration with the bariatric surgery team, especially the dietitian, pre– and postoperatively as
necessary, to validate data, determine recommendations, and develop a multidisciplinary treatment plan as indicated.
G. Mental Health Follow–Up
Further follow–up is recommended to the patient if, based on the assessment:
There is significant question related to the appropriateness for surgery and further assessment is needed, or
There are issues identified that if addressed pre–operatively could contribute to a positive post–op outcome.
Should there be a question by the bariatric surgery team regarding the patient's psychiatric appropriateness for surgery, the team can
refer the patient for a 2nd opinion in BHS or consult with a psychologist regarding psychological testing. At the time the surgery date
is set, a follow–up visit approximately one month post op is scheduled by the patient to evaluate the post operative adjustment as
well as the need for additional psychiatric intervention to maximize surgical success and patient satisfaction.
H. Support Group
A support group for post–operative patients will meet on a regular basis. There will also be group meetings during the pre–operative
period with participation by nutrition, BHS, surgery and other specialties as needed.
I. Prevention Screening
Prevention screening for obesity will be a part of well person care throughout the region.
J. Weight Loss
All patients must demonstrate up to 5% weight loss from time of entry into the dietary program until surgery in order to be considered
for surgery.
K. Physical Activity
An individualized physical activity plan shall be part of the pre–operative and post–operative care of the patient.
L. Specialty Consultations
Specialty consultations will be obtained based upon the recommendations of the PCP, anesthesiologist or surgeon.
M. Pharmacy Review
Review of medications to ensure that appropriate forms of medications with appropriate doses for a patient with a small stomach size
post–op.
N. Laboratory Review
In addition to screening tests for metabolic and nutritional disorders that are a part of the initial medical evaluation and routine
preadmission testing lab tests, CBC, BMP, Ferritin, FIBC, B12, 25–OH Vitamin D, Thiamine, red cell folate, and prealbumin shall be
ordered at 3, 6, 9, 12, 18, and 24 months post–surgery, and annually thereafter for all patients who have had Bariatric surgery.
FORMAL APPROVAL PROCESS:
Upon successful completion of all evaluations, including the recommendations of the multidisciplinary team, a decision concerning
the surgical treatment of the patient will be made by the OPMG Bariatric Surgeon. Patients will also be presented to the
multidisciplinary team if they have shown little or no progress after 6 nutritional visits. The team will discuss the case and make a
determination regarding the subsequent disposition of the patient. Options include (but are not limited to) referral to the OPMG
Bariatric Surgeon, referral to Behavioral Health or changing the nutritionist assigned to the patient. If the recommendation requires an
external referral, one will be generated by the OPMG Bariatric Surgeon and reviewed by the OPMG Chief of Surgery and the
Medical Management Department. If it is denied, the patient has the right to appeal the decision.
SURGERY:
Open Roux en Y Gastric Bypass (RYGP), laparoscopic Roux en Y Gastric Bypass (LRYGP), Laparoscopic Sleeve Gastrectomy
(LSG), and Laparoscopic Adjustable Gastric Bands (LAGB) are the standard procedures that will be performed as primary
procedures. The decision concerning which procedure shall be performed with be part of a shared educational discussion involving
the patient and surgeon. Patients who satisfy criteria but cannot be handled by our program will be referred to a tertiary center on an
individual basis upon the recommendation of the OPMG Bariatric Surgeons and Medical Management.
PERI–OPERATIVE CARE:
All procedures are performed at an accredited Bariatric Surgery Center of Excellence, Parma Community General Hospital (PCGH)
by an accredited surgeon. All inpatient and outpatient cases are monitored for length of stay and readmission rates. LAGB may be
considered as an outpatient procedure at the discretion of the operating surgeon based upon quality outcomes. All LAGB patients
will have a contrast upper GI series in the immediate postoperative period to document appropriate band placement.
POST–OPERATIVE CARE:
Post–operative care shall be provided by the operating surgeon at 10 days, 6 weeks, 3, 6, 9, 12, and 18 months after RYGB, LSG,
LRYGB and LAGB. They shall be seen by their PCP within the first month after surgery, as needed in the first two years after
surgery, and annually thereafter. For Laparoscopic Adjustable Gastric Bands, the first band fill will occur at the six week visit, and the
second at the three month visit. Subsequent fills will be based upon patient symptoms and weight loss, and patients will be seen on
an as needed basis by the operating surgeon at any time between the scheduled visits for adjustments based upon symptoms.
There is a Bariatric Surgeon on–call list, managed by physician scheduling, available for all providers to use as needed when urgent
or emergent consultation is considered.
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Bariatric Surgery (Gastroplasty): Clinical Library
At the 6 week post op visit with the surgeon patients are screened for depression using a standardized depression screening tool. If
depressed, the patient is referred back to BHS for further evaluation and follow–up. BHS will outreach the patient by telephone to
schedule a follow–up appointment.
Nutrition care post operatively will include a telephone follow–up at 10 days post op and office visits at 1, 3, 6, 9, 12, 18 and 24
months then yearly thereafter. Patients will also be encouraged to attend a Kaiser or non–Kaiser support group on a regular basis.
OUTCOMES:
Quarterly, the patients screened for depression at the 6 week post op visit and determined to be depressed will be monitored for
referral and follow–up in BHS. Outcome data on all patients are being recorded and will be analyzed on at least an annual basis.
Patient outcome data will also be entered into the National BOLD Database in order to maintain Center of Excellence status.
REFERENCES:
Bariatric Surgery for Morbid Obesity (including LASGB–Gastric Banding); Assessment of Kaiser Permanente Interregional New
Technologies Committee, November 14, 2005.
Laparoscopic Adjustable Gastric Banding; Assessment of Kaiser Permanente Interregional New Technologies Committee, February
26, 2007.
Bariatric Surgery Reduces Obesity–related Disease; Evidence–Based Healthcare & Public Health (2005) 9, 255–256
Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report;
National Institutes of Health, NIH Publication No. 98–4083, September, 1998, National Institutes of Health
Health Outcomes after Bariatric Surgery; Evaluation by Hayes, Inc., January, 2004.
Adams TD, Gress RE, Smith SC, et al. Long term mortality after gastric bypass surgery. N Engl J Med. 2007; 357:753–761.
Sjostrom L, Narbro K, Sjostrom D, et al. Effects of bariatric surgery and mortality in Swedish obese students. N Engl J Med. 2007;
357:741–752.
The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium. Perioperative Safety in the Longitudinal Assessment of
Bariatric Surgery. N Engl J Med. 2009; 361:445–454.
Bariatric Surgery – Surgical Indications (Adult). KP Interregional Bariatric Surgery Group Consensus Document, September, 2008.
Laparoscopic Sleeve Gastrectomy; Assessment of Kaiser Permanente Interregional New Technologies Committee, March 22, 2010.
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